NCT00482339

PCR-Based Detection of Bacterial Agents in Platelet Concentrates and Whole Blood

PCR-Based Detection of Bacterial Agents in Platelet Concentrates and Whole Blood (First Study)

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 2,000 (estimated)
• Sponsor: University of Jena · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

Using methods of molecular biology bacteria can be detected in blood. In comparison to conventional blood cultures "bacterial DNA" is isolated using a new sample preparation system in platelet apheresis concentrates and in the predonation whole blood of donors.

Detailed description

Bacterial contamination of platelet concentrates is discussed worldwide and according to literature occuring in 1:1000 to 1:5000 concentrates. Bacterial contaminated concentrates can in fact cause severe infections in patients. therefore this study initially intends to detect contamination with "bacterial DNA" in platelet aphereses concentrates. All sample donations are also examined by blood culture for contamination. To exclude already existing "infection" of the donor one tube of whole blood is taken in addition to the other legally required samples for the production of pharmaceutical medicine. All samples are anonymised before passed on for analysing.

Conditions

• Healthy

Timeline

• Start date: 2007-06-01
• Completion: 2009-07-01
• First posted: 2007-06-05
• Last updated: 2007-06-05

Locations

1 site across 1 country: Germany